Calibration of the Cloud DX Pulsewave Health Monitor (PAD-2A) Oscillometric Wrist Cuff Home Blood Pressure Monitor, According to the AAMI/ESH/ISO Universal Standard (ISO 81060-2: AMD_2020) (CCV-4)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Diastolic Pressure
研究概览
简要总结
The objective of this study is to calibrate the blood pressure measurements of the Pulsewave Health Monitor (PAD-2A) device to be within 5±8 mmHg of the average of the dual-observer measurements via an aneroid sphygmomanometer (reference device), as per the methodology described in the ISO 81060-2: AMD_2020 protocol.
详细描述
The plan for this study is to calibrate the blood pressure measurements of the PAD-2A device with the dual-observer blood pressure measurements via an aneroid sphygmomanometer (reference device), as per the ISO 81060-2: AMD_2020 protocol. The data will be collected and analyzed in order to calibrate the PAD-2A device blood pressure measurements to be within 5±8 mmHg of the average of the dual-observer auscultatory blood pressure measurements by adjusting the device algorithm.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ≥ 19 years of age (minimum 30% male/female)
- •Wrist circumference between 13.5 cm. - 23 cm. (5.3 in. - 9.1 in.):
- •Specifically for this test device, the wrist size of the consented participants will be distributed accordingly for a Gaussian distribution:
- •Lowest Octile: ≥ 13.5cm to < 14.7cm Lower Quarter: ≥ 13.5cm to < 15.9cm Lower-Middle Quarter: ≥ 15.9cm to < 18.3cm Upper-Middle Quarter: ≥ 18.3cm to < 20.7cm Upper Quarter: ≥ 20.7cm to ≤ 23.0cm Highest Octile: ≥ 21.9cm to ≤ 23.0cm
- •● Willing to volunteer to participate and to sign the study specific informed consent form
排除标准
- •Wrist circumference less than 13.5 cm. (5.3 in.) or greater than 23 cm. (9.1 in)
- •Hand or body tremors
- •Irregular heart rhythm (bigeminy, trigeminy, isolated ventricular premature beat (VPB), atrial fibrillation)
- •Korotkoff sound K5 not audible
- •A musculoskeletal disorder that prevents a non-invasive device to be inflated/deflated on the arm
- •Unwilling to volunteer to participate and to sign the study specific informed consent form
结局指标
主要结局
Diastolic Pressure
时间窗: From the start of manual inflation of the upper arm blood pressure cuff to the end of (manual) deflation of the upper arm blood pressure cuff (approximately 30-60 seconds)
Simultaneous auscultatory blood pressure measurements by 2 trained observers
Systolic Pressure
时间窗: From the start of manual inflation of the upper arm blood pressure cuff to the end of (manual) deflation of the upper arm blood pressure cuff (approximately 30-60 seconds)
Simultaneous auscultatory blood pressure measurements by 2 trained observers
次要结局
未报告次要终点